Continous Popliteal Block for Microvascular Free Flap Reconstruction in Ear, Nose and Throat Surgery

NCT03607227 | Completed Phase 4

• 1 other identifier: Region Skane 20180602
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the effects of a continuous popliteal block on postoperative pain and recovery after major ear, nose and throat surgery with microvascular free flap reconstruction using a fibula graft.

Conditions

Head and Neck Cancer; Pain, Musculoskeletal

Keywords

microsurgical free flaps; popliteal nerve block; head and neck cancer; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Postoperative pain assessed by VAS (ranging from 0 (no pain) to 10 (worst possible pain)).

  Change in pain in the operated leg, measured with visual analogue scale (VAS), between the two study groups (the two study arms described above). VAS assesses self-perceived pain. The scale ranges from 0 (meaning no pain at all) to 10 (meaning worst possible pain). Low VAS scores (representing no to low pain) are better than high VAS scores (representing severe pain).

  Assessment of pain using VAS three times a day during the first seven postoperative days, with follow-up at the first office visit three months after surgery.

Secondary Outcomes (4)

• Postoperative nausea, assessed by VAS (ranging from 0 (no nausea) to 10 (worst possible nausea)), and vomiting (yes/no).

  Assessment of nausea using VAS and occurence of vomiting (yes/no) three times a day during the first seven postoperative days, with follow-up assessment of nausea at the first office visit three months after surgery.

• Postoperative sensory and motor function in the operated leg assessed by a simplified scale (ranging from 0 to 2, see description below).

  Assessment of sensory and motor function using the scale described above three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.

• Ability of postoperative mobilization (sitting/standing/walking, with or without tools/aids).

  Assessment of level of mobilization (sitting/standing/walking) three times a day during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.

• Opioid consumption in the postoperative period.

  Notation of the amount of opioids (preparation, route and dose) consumed is noted daily during the first seven postoperative days, with follow-up assessment at the first office visit three months after surgery.

Study Arms (2)

Local anesthetic

ACTIVE COMPARATOR

Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.

Drug: Levobupivacaine

Saline

PLACEBO COMPARATOR

Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as in the active substance arm.

Drug: Saline Solution

Interventions

Levobupivacaine DRUG

Active substance. Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.

Local anesthetic

Saline Solution DRUG

Placebo. Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as the active substances.

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at Skåne University hospital department of ear, nose and throat surgery undergoing major resection of maxilla or mandible and reconstruction using free fibula graft.
• Preoperatively able to walk (with or without aid).

You may not qualify if:

• Neurological disease or peripheral neuropathy affecting the donor leg of the fibula graft.
• Conditions of coagulopathy, or treatment with anticoagulant drugs, that contraindicates peripheral nerve block according to local guidelines.
• Local anesthetic allergy.
• Inability to understand study information or answer questions.

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane University Hospital Lund, Divison of Anaestesia and Intensive Care

Lund, Skåne County, 22185, Sweden

Location

Related Publications (5)

• Marur S, Forastiere AA. Head and Neck Squamous Cell Carcinoma: Update on Epidemiology, Diagnosis, and Treatment. Mayo Clin Proc. 2016 Mar;91(3):386-96. doi: 10.1016/j.mayocp.2015.12.017.

  PMID: 26944243 BACKGROUND

• Ragbir M, Brown JS, Mehanna H. Reconstructive considerations in head and neck surgical oncology: United Kingdom National Multidisciplinary Guidelines. J Laryngol Otol. 2016 May;130(S2):S191-S197. doi: 10.1017/S0022215116000621.

  PMID: 27841135 BACKGROUND

• Dort JC, Farwell DG, Findlay M, Huber GF, Kerr P, Shea-Budgell MA, Simon C, Uppington J, Zygun D, Ljungqvist O, Harris J. Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):292-303. doi: 10.1001/jamaoto.2016.2981.

  PMID: 27737447 BACKGROUND

• Borgeat A, Blumenthal S, Lambert M, Theodorou P, Vienne P. The feasibility and complications of the continuous popliteal nerve block: a 1001-case survey. Anesth Analg. 2006 Jul;103(1):229-33, table of contents. doi: 10.1213/01.ane.0000221462.87951.8d.

  PMID: 16790658 BACKGROUND

• White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.

  PMID: 14570643 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Musculoskeletal Pain; Pain, Postoperative

Interventions

Levobupivacaine; Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Louise Walther Sturesson, MD, PhD

  Skåne University hospital, Region Skåne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 31, 2018
• Study Start: September 1, 2018
• Primary Completion: April 6, 2021
• Study Completion: April 7, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)